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OpenTrials
Completed

NCT Number: NCT03376295

Comparative Effectiveness of COPD Treatments

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Clinical Epidemiology, McGill University

Montreal, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015
  • Diagnosis of COPD and age ≥ 55 years

Exclusion criteria

  • Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
  • Asthma diagnosis

Treatment and study plan

LABA and the LAMA tiotropium (LABA-TIO)

Drug

combinational drug

Other names: FORVENT, SPIRIVA, SRIVASSO

LABA and an ICS (LABA-ICS)

Drug

combinational drug

Primary outcomes

  1. The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry

    Time frame: 12 Years

    The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.

Secondary outcomes

  1. The Rate of COPD Exacerbations

    Time frame: 12 years

    Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.

  2. The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)

    Time frame: 12 years

    The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Comparative Effectiveness of Combination Therapies in COPD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2017
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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